The document discusses key aspects of the TRIPS (Trade Related Aspects of Intellectual Property Rights) agreement. It outlines how TRIPS harmonized global intellectual property rules and established minimum standards of protection for patents, copyrights, trademarks and other IP. The document also examines how TRIPS provisions relate to public health issues like access to medicines and the use of flexibilities like compulsory licensing by countries. It analyzes the impact of stronger IP rules on the price of drugs and the role of generic competition in increasing access.

1. Presentation by:-
NESNAL NIRAULA
B.Pharm.3rd yr.

2.  Trade Related Aspects Of Intellectual Property
Rights 1995
 A integral part of WTO agreement like
◦ GATS: Trade And Services
◦ GATT: Tariffs And Trade
◦ TBT : Technical Barriers To Trade
 Joint effort of WHO and WTO that shows the
linkage between Trade and Health
 WTO dispute settlement mechanism

3.  WTO agreements allow the government to
take measures to restrict trade in pursuing
National Health Policy objectives.
 Specific health matters given below are taken
in consideration while taking the restrictions.
 Infectious Disease Control
 Food Safety
 Environment

4.  Tobacco
 Access to Drugs
 Health Services
 Food Security and Nutritions
 Emerging Issues of Biotechnology

5.  TRIPs Agreement deals with member states
obligation on a number of Intellectual Property
Rights
 Copyrights and related rights
 Trademarks*
 Geographical indications
 Industrial designs
 Patents *
 Layout designs of integrated circuits
 Protection of undisclosed information*
(*-topics relevant to health.)

6.  To encourage and reward creative work.
 To protect the investments in the development of
technology.
 To stimulate and ensure fair competition.
 To facilitate transfer of technology in the form of FDI,
joint ventures and licensing(Foreign direct
investment).
 To achieve the balance of rights and obligations.
 To make trade and health policies mutually
supportive.
 To ensure affordable access to existing drugs.
 To contribute to mutual advantage of producers and
users of technological knowledge.

7.  Members may, in formulating or amending their laws
and regulations, adopt measures necessary to protect
public health and nutrition, and to promote the public
interest in sectors of vital importance to their socio-
economic and technological development, provided
that such measures are consistent with the provisions
of this Agreement.
 Appropriate measures, provided that they are
consistent with the provisions of this Agreement, may
be needed to prevent the abuse of intellectual
property rights by right holders or the resort to
practices which unreasonably restrain trade or
adversely affect the international transfer of
technology.

8.  As in other WTO Agreements, non-
discrimination is a core TRIPS principle.
 Members must not discriminate on the basis of
the nationality of persons or companies (Articles
3, 4 and 5). In addition, Members cannot
discriminate between different fields of
technology in the availability and enjoyment of
patent rights.
 Nor can they discriminate in these areas on the
basis of the place of invention and whether
products are imported or locally produced
(Article 27.1).

11.  1/3rd of world population lack access to
essential medicines
 Access to essential medicines depends
critically on
Rational selection and use.
Sustainable and adequate financing
Reliable supply systems
Affordable prices

12.  Though price is only one factor but it is very
important one so,
 Recognizing the concern of, effect of trips
agreement on price of drugs the trips
agreement is interpreted and implemented in
a manner supportive of WTO Members’ right
to protect public health and, in particular, to
promote access to medicines for all”.

13.  The introduction of the higher TRIPS
standards has delayed the marketing of
generic versions of new medicines, and retard
in the competition they gain; in several
developing countries. So prices of new
medicines remain high for a longer time. This
could result in reduced access.

14. The key safeguards are:-
 provisions for early working (often referred to
as Bolar provision),
 parallel importation, and
 compulsory licensing.

15.  The Bolar provision allows testing and
regulatory approval of generic versions of a
drug before its patent expires. Thus, generic
producers can prepare for production of the
drug and its sale as soon as the patent
expires. In this way, a Bolar provision
facilitates the quick entry of generic drugs
into the market.

16.  Parallel importation refers to importation,
without the consent of the patent holder, of a
patented product that is marketed in another
country. Parallel importation allows one to “shop
around” for a good price. Example;-
 parallel importation also enables competition,
but in a different way.
 during WTO’s Ministerial Meeting in November
2001, the ministers clarified, in the Doha
Declaration on the TRIPS Agreement and Public
Health, that countries are free to use parallel
importation.

17.  A compulsory license is a license to use an invention
without the permission of the patent holder of the
invention.
 A compulsory license can be used to allow the
production and sale of generic versions of the drug
before expiry of the patent on the drug; thus, again,
increasing opportunities for competition .
 The basic rationale for a compulsory license is that,
as a patent is a chance granted by the government,
the government retains the right to limit that, if
necessary.
 Many countries, including many developed countries,
have provisions for compulsory licenses in their
national laws, and compulsory licenses are allowed
under TRIPS.

18.  TRIPS provides for a compulsory license to be
issued in reasons of national emergency or
extreme urgency, public non-commercial use
and other reasons like;-
◦ a case-by-case decision, which means a decision on
each drug separately;
◦ first trying to obtain a voluntary license from the patent
holder;
◦ adequate remuneration to be paid to the patent holder;
◦ being predominantly for the supply of the domestic
market (amended in January 2017);
◦ being non-exclusive and non-assignable.

19.  In January 2017, the TRIPS Agreement was
amended to include Article 31bis.
 The amendment provides the legal basis for
WTO Members to grant special compulsory
licenses exclusively for the production and
export of affordable generic medicines to other
Member States that cannot domestically produce
the needed medicines in sufficient quantities for
their patients .
 the safeguards provided for in TRIPS can be used
only when incorporated in the national law.

20.  It has to be new ("novelty");
 It must involve an "inventive step" (it must not be
obvious); and,
 It must have "industrial applicability" (it must be
useful).
 Moreover, details of the invention have to be
described in the application and therefore have
to be made public. This is referred to as
"disclosure".
 Disclosure has to be sufficient to enable a person
skilled in the area to reproduce the invention.
Members may also require the patent applicant
to reveal the best method for carrying it out.

21. Regarding eligibility for patenting, governments
can refuse to grant patents for three reasons that
may relate to public health:-
 Inventions whose commercial exploitation needs
to be prevented to protect human, animal or
plant life or health;
 Diagnostic, therapeutic and surgical methods for
treating humans or animals;
 plant and animal inventions other than micro-
organisms, and essentially biological processes
for the production of plants or animals other
than non-biological and microbiological
processes.

22.  Patents provide the patent owner with the
legal means to prevent others from making,
using, or selling the new invention for a
limited period of time.
 It is not, however, a permit to put a product
on the market.
 Patented pharmaceuticals still have to go
through rigorous testing and approval before
they can be put on the market.

25.  Condition for issuing compulsory license is that
patent holder should receive adequate
remuneration but trips doesn’t define
`adequate`, which is flexible.
 freedom of selection of criteria of patentability.
◦ Either* flexible criteria-formulation and isomers as novel
and inventive task- allows pharmaceutical companies to
apply for additional patents,
 provides them with opportunities to expand the duration of
protection beyond that of the original patent.
◦ Or* strict criteria-encourage for new generic production.

26.  As the TRIPS Agreement does not define the
terms "new", "inventive step" and "non-
obvious", national patent laws vary in how
they construe these terms for the purposes of
evaluating patent applications.

27.  Datas are submitted to regulatory authorites
to obtain marketing authorization for new
drugs.
 These registration data have to be protected
against disclosure, and against unfair
commercial use.
 The national authorities may not share them
with competing companies and aid for
providing incentives to the new drug
development and reward the developer.

28.  Trademarks are another form of intellectual
property and recognized as such in the TRIPS
Agreement. National trademark laws should
not hinder pro-public health measures such
as generic prescription, generic substitution
and/ or requirements that a drug’s label
includes the generic name.

30. There have been cases of counterfeiting of both
patented and non-patented drugs. Counterfeit
drugs, which often contain few or no active
ingredients and may actually be harmful to
health, are a major problem in many developing
countries, notably in sub-Saharan Africa.
Counterfeit drugs are recognized as a problem
undermining the effectiveness of drug therapy.
Many of the counterfeit products on local
markets in these countries are imported rather
than locally produced. The TRIPS Agreement
addresses this issue in three main ways.

32.  Over 40 countries provided no product
patent protection for pharmaceuticals prior to
the launching of the negotiation of the TRIPS
Agreement .
 A few of these countries did not provide
process protection in this area as well.
 The duration of patents was less than 20
years in many countries.

33.  WTO Members provide patent protection for
any invention: whether a product (such as a
medicine) or a process (such as a method of
producing the chemical ingredients for a
medicine).
 Patent protection has to last at least 20 years
from the date the patent application was
filed.

34.  World Intellectual Property Organization
(WIPO): A specialized United Nations Agency,
established in 1961 to deal with matters
relating to IPR at the global level.
 International Union for the Protection of New
Varieties of Plants (UPOV): A convention
agreed among the developed countries in
1961 to protect the rights of plant breeders.

35. Thank you